Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter aortic valve replacement.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: 1. whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation; 2. the determinants of postoperative ascending aortic dilatation.
Detailed description
Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.
Interventions
- Procedure Transcatheter aortic valve replacement
All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis
Primary outcome measures
- Rate of ascending aortic dilatation [Time frame: 1-year and 2-year]
Secondary outcome measures (2)
- Rate of all-cause mortality [Time frame: 1-year and 2-year]
- Rate of adverse aortic events [Time frame: 1-year and 2-year]
Eligibility criteria
Inclusion criteria
- Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less;
- Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more;
- High risk of surgical aortic valve replacement;
- Suitability for a transfemoral vascular access.
Exclusion criteria
- Dominant aortic regurgitation;
- History of surgical or transcatheter aortic valve replacement;
- History of aortic surgery;
- Connective tissue disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Med — Beijing
Publications
- An K, Zhang F, Ouyang W, Pan X. Blood flow dynamics in the ascending aorta of patients with bicuspid aortic valve before and after transcatheter aortic valve replacement: a computational fluid dynamics study. BMC Cardiovasc Disord. 2024 Dec 20;24(1):717. doi: 10.1186/s12872-024-04394-w. PMID 39702010
Identifiers
NCT: NCT05739253 · 2021-1602